Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)

Johns Hopkins University

Status: Enrolling

Conditions: Hypertension; Hyperlipidemias; Stroke; Recruitment; Overweight and Obesity; Cardiovascular Diseases; Diabetes Type 2

Treatments: Behavioral: EHR-informed Recruitment Method of Contact; Behavioral: Educational Text-Messages and Connection to Cardiovascular Research Opportunities

Study type: Interventional

Funder types: Other

Identifiers

NCT06347484

IRB00411716

Details and patient eligibility

About

The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning platform designed to increase diversity in cardiovascular disease research among women and Black and Latino adults. CONNECT will deploy electronic health record (EHR)-informed and community-engaged recruitment approaches to identify and recruit adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on cardiovascular health and research participation via text message. Participants will also have the opportunity to be connected to ongoing cardiovascular research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The CONNECT platform will be used to evaluate recruitment methods. The investigators hypothesize the proportion of women and Black and Latin adults enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. Investigators also hypothesize that participating in CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials.

Full description

The CONNECT project, titled "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials," seeks to establish an comprehensive learning platform aimed at improving diversity and representation in cardiovascular research. It encompasses three primary objectives:

1. Identifying best practices for research recruitment and engagement among women and Black and Latino adults.
2. Increasing participation in cardiovascular health research among women and Black and Latino adults.
3. Improving trust in and awareness of cardiovascular research among women and Black and Latino adults.

A multi-method recruitment campaign will be implemented, utilizing both electronic health record (EHR)-informed and community-based strategies. A sub-study will be conducted to understand the effectiveness of EHR-informed recruitment. This sub-study will randomly assign a subsample of individuals identified in the EHR to one of three outreach modalities: patient portal message, email, and postal mail. Enrollment yield will be calculated for each recruitment method, with logistic regression modeling estimating the odds of enrollment by recruitment outreach type, both overall and among different demographic groups.

Upon enrollment, participants will specify preferences for receiving text messages regarding heart health, research education, and study opportunities. Messaging will focus on cardiovascular health prevention, management strategies, and research processes, with the aim of fostering trust in research within the community. Pre-post surveys will be distributed to assess changes in clinical trial awareness, trust in medical research, and willingness to participate in trials at baseline, 6 months, and 12 months post-enrollment. Interaction terms will be used to evaluate differences in outcomes by race, ethnicity, and sex.

The process for matching participants to research within the CONNECT project involves individual researchers submitting requests to the CONNECT study team for access to the learning community as a recruitment resource, followed by approval Institutional Review Board (IRB) approval. Upon access, researchers can retrieve, and view records of participants matched to respective studies, ensuring access only to data pertinent to the research objectives. Verification of IRB approval is mandated, and the CONNECT study team will request documentation from the individual research team's IRB to confirm compliance before granting access. Researchers using CONNECT must document eligibility and enrollment data for each CONNECT participant matched to the participants study. Proportions of participants matched to and enrolled in ongoing research studies will be tabulated and compared across demographic groups.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is 18 years or older
• Residing in the US
• Self-identifies as having cardiovascular disease or cardiovascular risk factors
• Has a mobile phone and is willing to receive text-messages
• Can read in English or Spanish

Exclusion criteria

• Unwilling or unable to provide informed consent

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 4 patient groups

Educational Text-Messages and Connection to Cardiovascular Research Opportunities

Experimental group

Description:

All participants who enroll in CONNECT, regardless of method of contact, will receive educational text messages and connection to cardiovascular research opportunities.

Treatment:

Behavioral: Educational Text-Messages and Connection to Cardiovascular Research Opportunities

EHR-Informed Recruitment Sub-Study #1, Arm #1: Contact Method, Patient Portal Message

Active Comparator group

Description:

Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via the patient portal message. This message will invite the participant to join CONNECT.

Treatment:

Behavioral: EHR-informed Recruitment Method of Contact

EHR-Informed Recruitment Sub-Study #1, Arm #2: Contact Method, Email

Active Comparator group

Description:

Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via email. This message will invite the participant to join CONNECT.

Treatment:

Behavioral: EHR-informed Recruitment Method of Contact

EHR-Informed Recruitment Sub-Study #1, Arm #3: Contact Method, Postal Mail

Active Comparator group

Description:

Potential participants will be identified using an EHR query and will be randomized to receive a recruitment message via postal mail. This message will invite the participant to join CONNECT.

Treatment:

Behavioral: EHR-informed Recruitment Method of Contact